Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:31 PM
Ignite Modification Date:
2025-12-24 @ 5:31 PM
NCT ID:
NCT02222168
Eligibility Criteria:
Inclusion criteria:
1. Healthy male and female volunteers
2. Age 18 (incl.) to 50 (incl.) years
3. Body mass index (BMI) range: 18.5 (incl.) to 29.9 (incl.) kg/m2
Exclusion criteria:
1. Any evidence of a clinically relevant concomitant disease
2. Any finding of the medical examination (including BP, PR and ECG) deviating from normal and of clinical relevance
3. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
4. Surgery of the gastrointestinal tract (except appendectomy)
5. Diseases of the central nervous system (including but not limited to any kind of seizures, stroke or psychiatric disorders)
6. History or evidence of relevant orthostatic reaction, fainting spells or blackouts, occurrence of syncopes, brady- or tachycardia in the anamnesis.
7. Positive pregnancy test
8. No adequate contraception during the study and until 1 month of study completion, i.e. intrauterine device (IUD), sexual abstinence (for at least 1 month prior to enrolment), or surgical sterilisation (incl. hysterectomy). Females, who are not surgically sterile will be asked to additionally use barrier contraception methods (e.g. condom, diaphragm with spermicide)
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT02222168
Study Brief:
Protocol Section:
NCT02222168